Effect of Reproductive Tract Microbiota on Pregnancy Outcome in Patients Accepted In-vitro Fertilization/Intracytoplasmic Sperm Injection and Embryo Transfer
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
A single center，observational cohort study to explore the relationship between reproductive tract microbiota and pregnancy outcome in the patients accepted IVF/ICSI. To investigate whether there is a correlation between reproductive tract microbiota and IVF/ICSI outcomes. Whether there are differences in reproductive tract microbiota (such as vagina, follicular fluid, uterine cavity, etc.) in patients with different pregnancy outcomes.
详细描述
A single center，observational cohort study will enroll 120 infertile participants and then divide them into 3 groups: 1)Male infertility；2)Recurrent implantation failure; 3)Recurrent spontaneous abortion. The study will last for 1 year and recruit participants in Reproductive medicine center of Peking university third hospital. Each participant will be followed up for at least 1 year. Collect samples and record information at the first month, then follow-up 2 months to record the pregnancy outcomes. DNA will be extracted from the samples and then have sequence to figure out the compositions of microbiota.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The sampling cycle of all samples requires no use of glucocorticoids, antibiotics and vaginal drugs within the cycle of this month; No cervical treatment within a week; No irrigation, asexual life within 5 days; Strict contraception in this month;
- •Male infertility (Related tests were normal, because the male factor alone required the first IVF/ICSI cycle; Follow-up of included patients was conducted to determine whether embryo transplantation was performed, and the score of transferred embryos was recorded, and the final control group would be confirmed after achieving clinical pregnancy) OR Recurrent implantation failure (Previous ≥3 consecutive embryo transfer failures) OR Recurrent spontaneous abortion (≥2 consecutive spontaneous abortions or embryo damage)
排除标准
- •Acute genital tract inflammation (including vagina, cervix, endometrium and pelvic cavity)
- •Previous diagnosis of intrauterine adhesion or mechanical damage to the endometrium; drugs and surgery can not restore the function (endometrium thickness <7mm in the window period before transplantation)
- •Untreated hydrosalpinx, submucosal or >4cm intramuscular uterine fibroids, adenomyosis, stage III-IV endometriosis confirmed by surgery, endometritis diagnosed by pathology and other definite factors might affect implantation
- •Chromosomal abnormalities in couples may lead to miscarriage, fetal malformation and other diseases
- •Previous examination indicated the existence of DOR (FSH≥9U/L and/or AMH ≤1.1ng/ml and/or AFC≤5-7)
- •Those with polycystic ovary syndrome, high prolactinemia and other ovulation disorders
- •Those with congenital adrenal hyperplasia, hypothyroidism/hyperthyroidism, diabetes, metabolic syndrome and other endocrine and metabolic diseases
- •BMI less than 18 or more than 25
- •Previous autoimmune diseases such as anti-heart coagulation syndrome, sjogren's syndrome and rheumatoid arthritis
- •Prethrombotic hypercoagulability or family history of thrombosis
- •Female genital tract deformities (whether or not surgically corrected)
- •Those within the programme of oocyte or sperm donor
- •Those with previous history of various types of cancer or serious systemic diseases (such as heart, lung and blood diseases) or mental diseases
结局指标
主要结局
Clinical pregnancy rate
时间窗: 4 weeks after embryo transfer
One or more observed gestational sac or definitive clinical signs of pregnancy under ultrasonography at 4 weeks after embryo transfer (including clinically documented ectopic pregnancy)
次要结局
- Microbiota ratio(About 2 months later after samples collection)
- Available embryo(72 hours after oocyte retrieval)
- Ongoing pregnancy rate(10 weeks after embryo transfer)
- Live birth rate(After 24 weeks of gestation)
- Good quality embryo(72 hours after oocyte retrieval)
- Oocyte retrieval(36 hours after HCG injection)
- Fertilization rate(16-20 hours after oocyte retrieval)
- Endometrium thickness(On the day of embryo transfer)
- Implantation rate(30 days after embryo transfer)
研究者
Li Rong
Director of Reproductive Medical Center
Peking University Third Hospital